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trastuzumab plus paclitaxel breast cancer

Mette S van Ramshorst, Erik van Werkhoven, Aafke H Honkoop, Vincent O Dezentjé, Irma M Oving, Ingrid A Mandjes, Inge Kemper, Carolien H Smorenburg, Jacqueline M Stouthard, Sabine C Linn, Gabe S Sonke
BACKGROUND: The addition of pertuzumab to neoadjuvant trastuzumab-based chemotherapy improves pathologic complete response rates in HER2-positive breast cancer. However, increased toxicity has been reported with the addition of pertuzumab, and this may differ between various chemotherapy backbone regimens. We evaluated toxicities of pertuzumab when added to either FEC-T (5-fluorouracil, epirubicin, cyclophosphamide, trastuzumab) or weekly paclitaxel, trastuzumab, carboplatin (PTC). METHODS: The TRAIN-2 study is a neoadjuvant randomized controlled trial in stage II and III HER2-positive breast cancer (NCT01996267)...
October 2016: Breast: Official Journal of the European Society of Mastology
Hirofumi Mukai, Toshiaki Saeki, Kenjiro Aogi, Yoichi Naito, Nobuaki Matsubara, Takashi Shigekawa, Shigeto Ueda, Seiki Takashima, Fumikata Hara, Tomonari Yamashita, Shoichi Ohwada, Yasutsuna Sasaki
Human epidermal growth factor receptor 3 (HER3) expression in lung and breast cancers has a negative impact on survival. Patritumab, a human anti-HER3 monoclonal antibody, has shown anticancer activity in preclinical models. This study examined the safety and pharmacokinetics of patritumab in combination with trastuzumab and paclitaxel in patients with HER2-overexpressing metastatic breast cancer. In this open-label, multicenter, dose-escalation, phase Ib study, patients received patritumab 9 or 18 mg/kg plus trastuzumab and paclitaxel at known tolerated doses...
July 25, 2016: Cancer Science
Binghe Xu, Xichun Hu, Hong Zheng, Xiaojia Wang, Qingyuan Zhang, Shude Cui, Donggeng Liu, Ning Liao, Rongcheng Luo, Qiang Sun, Shiying Yu
Trastuzumab is the backbone of HER2-positive early breast cancer (eBC) and metastatic breast cancer (mBC) treatment, but limited data exist as to re-treatment in relapsed patients. In this prospective, single arm, multicenter trial, we assessed efficacy and safety of trastuzumab and taxane combination in Chinese patients with HER2-positive mBC relapsed after prior (neo)adjuvant trastuzumab. Patients with previous (neo)adjuvant trastuzumab treatment for≥9 weeks and a relapse-free interval ≥6 months were assigned to trastuzumab treatment with paclitaxel or docetaxel...
May 27, 2016: Oncotarget
Ahmad Awada, Ramon Colomer, Kenichi Inoue, Igor Bondarenko, Rajendra A Badwe, Georgia Demetriou, Soo-Chin Lee, Ajay O Mehta, Sung-Bae Kim, Thomas Bachelot, Chanchal Goswami, Suryanarayan Deo, Ron Bose, Alvin Wong, Feng Xu, Bin Yao, Richard Bryce, Lisa A Carey
Importance: Efficacious ERBB2 (formerly HER2 or HER2/neu)-directed treatments, in addition to trastuzumab and lapatinib, are needed. Objective: To determine whether neratinib, an irreversible pan-ERBB tyrosine kinase inhibitor, plus paclitaxel improves progression-free survival compared with trastuzumab plus paclitaxel in the first-line treatment of recurrent and/or metastatic ERBB2-positive breast cancer. Design, Setting, and Participants: In the randomized, controlled, open-label NEfERT-T trial conducted from August 2009 to December 2014 at 188 centers in 34 countries in Europe, Asia, Africa, and North America, 479 women with previously untreated recurrent and/or metastatic ERBB2-positive breast cancer were randomized to 1 of 2 treatment arms (neratinib-paclitaxel [n = 242] or trastuzumab-paclitaxel [n = 237])...
April 14, 2016: JAMA Oncology
Anthony F Yu, Carlos Manrique, Shawn Pun, Jennifer E Liu, Elton Mara, Martin Fleisher, Sujata Patil, Lee W Jones, Richard M Steingart, Clifford A Hudis, Chau T Dang
INTRODUCTION: Myocardial strain imaging and blood biomarkers have been proposed as adjuncts to left ventricular ejection fraction (LVEF) monitoring for the early detection of cardiotoxicity during cancer therapy. We report the results of a preplanned cardiac safety analysis of global longitudinal strain (GLS), and troponin-I (TnI) and brain natriuretic peptide (BNP) levels in the phase II study of paclitaxel, trastuzumab, and pertuzumab (THP) for metastatic HER2-positive breast cancer...
April 2016: Oncologist
Moisés Uriarte-Pinto, Ángel Escolano-Pueyo, Vicente Gimeno-Ballester, Oihana Pascual-Martínez, María Reyes Abad-Sazatornil, María José Agustín-Ferrández
BACKGROUD: Neoadjuvant treatment based on the combination of trastuzumab plus chemotherapy is the standard of care in patients with HER2-positive early or locally advanced breast cancer. The concurrent use of trastuzumab, anthracyclines and taxanes is frequently used in this setting despite the potential cardiotoxicity of both anthracyclines and trastuzumab. However, not much information is available about this chemotherapy scheme. OBJECTIVE: We wanted to evaluate the efficacy and safety profile of the combination of trastuzumab, liposome-encapsulated doxorubicin and paclitaxel as neoadjuvant scheme...
April 2016: International Journal of Clinical Pharmacy
T Zhu, C L Liu, Y F Zhang, Y H Liu, F P Xu, J Zu, G C Zhang, X R Li, N Liao, K Wang
The aim of the present study is to investigate the efficacy and safety of dose-dense (biweekly) carboplatin and paclitaxel as a neoadjuvant treatment for operable breast cancer. Patients with previously untreated breast cancer (stages Ic-III) were treated with four cycles of paclitaxel (175 mg/m(2), intravenous drip, D1) and carboplatin (area under the curve of 5, D1). Patients with HER2+ disease simultaneously received trastuzumab (6 mg/kg initial dose with subsequent doses of 4 mg/kg biweekly). The primary endpoint was a pathologically complete response (pCR)...
February 2016: Breast Cancer Research and Treatment
Michael Untch, Christian Jackisch, Andreas Schneeweiss, Bettina Conrad, Bahriye Aktas, Carsten Denkert, Holger Eidtmann, Hermann Wiebringhaus, Sherko Kümmel, Jörn Hilfrich, Mathias Warm, Stefan Paepke, Marianne Just, Claus Hanusch, John Hackmann, Jens-Uwe Blohmer, Michael Clemens, Silvia Darb-Esfahani, Wolfgang Daniel Schmitt, Serban Dan Costa, Bernd Gerber, Knut Engels, Valentina Nekljudova, Sibylle Loibl, Gunter von Minckwitz
BACKGROUND: In metastatic breast cancer, nab-paclitaxel has been shown to significantly increase progression-free survival compared with solvent-based paclitaxel. The GeparSepto (GBG 69) trial assessed whether weekly nab-paclitaxel could increase the proportion of patients achieving pathological complete response compared with weekly solvent-based paclitaxel, both followed by epirubicin plus cyclophosphamide as neoadjuvant treatment. METHOD: In a phase 3 randomised trial, we enrolled patients with previously untreated unilateral or bilateral primary invasive breast cancer and randomly assigned them in a 1:1 ratio using dynamic allocation and Pocock minimisation by breast cancer subtype, Ki67 and SPARC expression...
March 2016: Lancet Oncology
L Biganzoli, M Aapro, Sibylle Loibl, Hans Wildiers, Etienne Brain
Along with anthracyclines, taxanes are the most active cytotoxics in breast cancer (BC). Balancing efficacy against toxicity in older patients with reduced physiological reserves and significant comorbidities is both important and difficult. This is especially so given the under-representation of elderly patients in major trials and a consequent lack of evidence for drug, dose and schedule. However, BC is frequent in elderly women, who are a growing proportion of the population. Careful consideration of their care is therefore imperative...
February 2016: Cancer Treatment Reviews
Nobushige Yabe, Shinji Murai, Yoko Harada, Takahiro Yokose, Takamichi Yokoe, Ippei Oto, Takahisa Yoshikawa, Kenjiro Kitasato, Hirotomo Shimizu, Hiromitsu Jinno, Yuko Kitagawa
A 51-year-old woman had previously received treatment for breast cancer at another hospital but had refused early and aggressive treatment. Therefore, she was treated with symptomatic therapy. As her disease progressed, the patient wished to receive palliative care, and was transferred to a palliative care hospital. However, based on her general condition, it was determined that aggressive treatment should not be abandoned, and she was referred to our hospital for treatment. During her initial visit, the patient was found to have left breast cancer with chest wall invasion, right breast metastasis, multiple liver and lung metastases, left pleural effusion accompanied by pleural dissemination, and left upper limb edema...
November 2015: Gan to Kagaku Ryoho. Cancer & Chemotherapy
Lu Yao, Juan Zhang, Yiqiang Liu, Tao Ouyang, Jinfeng Li, Tianfeng Wang, Zhaoqing Fan, Tie Fan, Benyao Lin, Yuntao Xie
BACKGROUND: We recently showed HER2-positive breast cancers are less likely to respond to neoadjuvant anthracycline chemotherapy. Here, we investigated whether HER2-positive breast cancers responded to sequential neoadjuvant anthracycline followed by paclitaxel plus carboplatin regimen in the absence of trastuzumab. METHODS: Women (n=372) with operable primary breast cancer initially received two cycles of neoadjuvant anthracyclines, the clinical tumor response was assessed, then patients were received four cycles of paclitaxel plus carboplatin regimen...
December 2015: Chinese Journal of Cancer Research, Chung-kuo Yen Cheng Yen Chiu
Lisa A Carey, Donald A Berry, Constance T Cirrincione, William T Barry, Brandelyn N Pitcher, Lyndsay N Harris, David W Ollila, Ian E Krop, Norah Lynn Henry, Douglas J Weckstein, Carey K Anders, Baljit Singh, Katherine A Hoadley, Michael Iglesia, Maggie Chon U Cheang, Charles M Perou, Eric P Winer, Clifford A Hudis
PURPOSE: Dual human epidermal growth factor receptor 2 (HER2) targeting can increase pathologic complete response rates (pCRs) to neoadjuvant therapy and improve progression-free survival in metastatic disease. CALGB 40601 examined the impact of dual HER2 blockade consisting of trastuzumab and lapatinib added to paclitaxel, considering tumor and microenvironment molecular features. PATIENTS AND METHODS: Patients with stage II to III HER2-positive breast cancer underwent tumor biopsy followed by random assignment to paclitaxel plus trastuzumab alone (TH) or with the addition of lapatinib (THL) for 16 weeks before surgery...
February 20, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Edith A Perez, Karla V Ballman, Kathy S Tenner, E Aubrey Thompson, Sunil S Badve, Helen Bailey, Frederick L Baehner
IMPORTANCE: The presence of tumor-infiltrating lymphocytes at diagnosis is reported to be prognostic in triple-negative breast cancer. OBJECTIVE: To evaluate the association of stromal tumor-infiltrating lymphocytes (STILs) with recurrence-free survival (RFS) in women with human epidermal growth factor receptor 2 (HER2)-positive breast cancer treated with chemotherapy or chemotherapy plus trastuzumab in the N9831 trial. DESIGN, SETTING, AND PARTICIPANTS: Hematoxylin-eosin-stained tumor slides from patients with early-stage HER2-positive breast cancer in 2 of the 3 arms of the N9831 trial were assessed for STILs at an academic medical center...
January 2016: JAMA Oncology
Neil M Iyengar, Monica N Fornier, Steven M Sugarman, Maria Theodoulou, Tiffany A Troso-Sandoval, Gabriella M D'Andrea, Pamela R Drullinsky, Devika Gajria, Shari B Goldfarb, Elizabeth A Comen, Diana E Lake, Shanu Modi, Tiffany A Traina, Mario E Lacouture, Melanie F Chen, Sujata Patil, José Baselga, Larry Norton, Clifford A Hudis, Chau T Dang
BACKGROUND: Dual anti-HER2 therapy is effective for HER2-amplified breast cancer. Weekly paclitaxel, trastuzumab, and full-dose lapatinib (PTL) is not feasible because of grade 3 diarrhea. We conducted a phase II feasibility study of dose-dense (DD; every other week) PTL ( identifier, NCT01827163). PATIENTS AND METHODS: Eligible patients had HER2-positive breast cancer, tumor size ≤ 3 cm, and negative nodes. Treatment included paclitaxel (175 mg/m(2) × 4, every 2 weeks with pegfilgrastim), trastuzumab (4 mg/kg load and then 2 mg/kg weekly), and lapatinib (1000 mg daily)...
April 2016: Clinical Breast Cancer
Pooja P Advani, Karla V Ballman, Travis J Dockter, Gerardo Colon-Otero, Edith A Perez
PURPOSE: Significant improvement in survival outcomes has been established with the addition of trastuzumab to adjuvant chemotherapy for human epidermal growth factor receptor 2 (HER2) -positive early breast cancer treatment. However, trastuzumab may increase the risk of cardiac toxicity, and long-term evaluation of its incidence and risk factors are warranted. METHODS: NCCTG (Alliance) N9831 trial compared adjuvant doxorubicin and cyclophosphamide (AC) followed by either weekly paclitaxel (arm A); paclitaxel then trastuzumab (arm B); or paclitaxel plus trastuzumab followed by trastuzumab alone (arm C) in patients with HER2-positive breast cancer...
February 20, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Vinay Varadan, Sitharthan Kamalakaran, Hannah Gilmore, Nilanjana Banerjee, Angel Janevski, Kristy L S Miskimen, Nicole Williams, Ajay Basavanhalli, Anant Madabhushi, Kimberly Lezon-Geyda, Veerle Bossuyt, Donald R Lannin, Maysa Abu-Khalaf, William Sikov, Nevenka Dimitrova, Lyndsay N Harris
To best define biomarkers of response, and to shed insight on mechanism of action of certain clinically important agents for early breast cancer, we used a brief-exposure paradigm in the preoperative setting to study transcriptional changes in patient tumors that occur with one dose of therapy prior to combination chemotherapy. Tumor biopsies from breast cancer patients enrolled in two preoperative clinical trials were obtained at baseline and after one dose of bevacizumab (HER2-negative), trastuzumab (HER2-positive) or nab-paclitaxel, followed by treatment with combination chemo-biologic therapy...
February 1, 2016: International Journal of Cancer. Journal International du Cancer
V F Semiglazov, V V Semiglazov, O L Petrenko, A V Komyakhov, G A Dashyan, R M Paltuev, T Yu Semiglazova, A G Manikhas, A A Bozhok, I A Lalak
In the randomized phase 2 study there was evaluated the efficacy of neoadjuvant endocrine treatment (anastrozole, exemestane) in comparison with chemotherapy (doxorubicin plus paclitaxel). Preoperative endocrine therapy was well tolerated. There was a trend towards higher overall rates of objective response and breast conserving surgery (BCS) among patients with tumors expressing high levels of ER (luminal A) in endocrine therapy group compared with chemotherapy group (43% vs 24%; p = 0,054). In HER2-positive breast cancer patients the addition of trastuzumab to neoadjuvant chemotherapy improved the overall and pathological complete response...
2015: Voprosy Onkologii
Sara A Hurvitz, Fabrice Andre, Zefei Jiang, Zhimin Shao, Max S Mano, Silvia P Neciosup, Ling-Min Tseng, Qingyuan Zhang, Kunwei Shen, Donggeng Liu, Lydia M Dreosti, Howard A Burris, Masakazu Toi, Marc E Buyse, David Cabaribere, Mary-Ann Lindsay, Shantha Rao, Lida Bubuteishvili Pacaud, Tetiana Taran, Dennis Slamon
BACKGROUND: mTOR inhibition reverses trastuzumab resistance via the hyperactivated PIK/AKT/mTOR pathway due to PTEN loss, by sensitising PTEN-deficient tumours to trastuzumab. The BOLERO-1 study assessed the efficacy and safety of adding everolimus to trastuzumab and paclitaxel as first-line treatment for patients with HER2-positive advanced breast cancer. METHODS: In this phase 3, randomised, double-blind trial, patients were enrolled across 141 sites in 28 countries...
July 2015: Lancet Oncology
Liang Huang, Sheng Chen, Wentao Yang, Binghe Xu, Tao Huang, Hongjian Yang, Hong Zheng, Yongsheng Wang, Erwei Song, Jin Zhang, Shude Cui, Da Pang, Lili Tang, Yutao Lei, Cuizhi Geng, Zhiming Shao
This trial was designed to compare the efficacy and safety between epirubicin (E) and carboplatin (C) in combination with paclitaxel (P) and trastuzumab (H) in neoadjuvant setting. In 13 Chinese cancer centers, 100 patients with HER2-positive, locally advanced breast cancer were 1:1 randomized to receive medication as follows: trastuzumab and paclitaxel weekly combined with carboplatin weekly for PCH group, or epirubicin every 3 weeks for PEH group. Patients were given 4 to 6 cycles of chemotherapy. The primary endpoint was pathologic complete response (pCR) rate, which was no significant difference in PCH and PEH regimen (39...
July 30, 2015: Oncotarget
Satoshi Nagashima, Takayoshi Kiba, Yoshikazu Ogawa, Takuya Mura, Sayoko Kajiume, Yuuko Okada, Nao Morii, Hirotoshi Takahashi, Yasunori Ichiba, Hiroyasu Yamashiro
Here, we report about a 60-year-old woman with metastatic breast cancer who was successfully treated for paclitaxelinduced peripheral neuropathy with duloxetine. She was administered trastuzumab plus paclitaxel(PTX)combination therapy that was ultimately discontinued because of grade 3 peripheral neuropathy detected on day 15, according to the CTCAE (v4.0). She was administered duloxetine on day 90 after the end of the previous therapy because of the peripheral neuropathy. Thereafter, the peripheral neuropathy decreased to grade 1, which enabled PTX administration on her request...
May 2015: Gan to Kagaku Ryoho. Cancer & Chemotherapy
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